Reference substances refer to the standard substances used for identification, checking and content determination. The preparation and verification of reference substances plays a crucial role in the development and registration of generic drugs. This process helps to ensure that the quality and efficacy of the generic drug matches the RLD, and also meets the safety, efficacy and consistency requirements of the regulatory authorities.
Our Services
As a professional generic pharmaceutical services company, Alfa Chemistry is committed to providing our clients with comprehensive preparation and verification of reference substances services. We specialize in identifying, isolating, preparing, and purifying reference substances. We offer reference substances that meet R&D purity requirements, cater to the specific needs of our clients, and support impurity removal and impurity control limit studies in generic drug process research.
Separation and Purification
Drug impurities can be categorized into process impurities, degradation impurities, impurities brought in from starting materials or reagents, etc. Separation, preparation and study of impurities are essential to the quality study and safety evaluation process of drugs.
Our company provides affordable and efficient preparation of controls with higher purity and higher recovery. Our purification and separation methods mainly include crystallization, column chromatography, preparative thin layer chromatography, preparative chromatography and salt formation, acid-base method and so on.
In addition, we provide detailed separation and purification reports according to customers' needs, including the separation and purification process, purity test results and quality assessment.
Identification of Unknown Impurities
Identification of unknown impurities is a critical step in ensuring the purity of a drug. Our goal is to identify and quantify all unknown impurities in APIs and formulations to ensure that they do not pose a potential risk to patient health.
- We analyze preliminary impurities by methods such as liquid chromatography and gas chromatography.
- We identify the structure of unknown impurities through analytical techniques such as mass spectrometry and nuclear magnetic resonance.
- We accurately quantify impurities using UV-Vis spectroscopy, chromatography, and other techniques.
Structure Confirmation
Structure confirmation is the process of confirming the exact structure of the molecule, which is critical to the safety and efficacy of a drug. We perform structural analysis of APIs and impurities through techniques such as X-ray crystallography, mass spectrometry, and nuclear magnetic resonance, and can compare computational chemistry with experimental data to further validate the structure.
We provide detailed structure confirmation reports in compliance with regulatory requirements, including structure diagrams, analytical data and validation results, to help our clients' products complete filings and obtain successful approvals.
Our Advantages
- We have many years of experience in impurity research and preparation.
- We have advanced and high-precision analytical instruments to ensure the accuracy of analytical results.
- Our team consists of experienced chemists and analysts to provide professional services.
- We strictly follow international high quality standards and norms to ensure the quality and reliability of our services.
- We follow laboratory practices to ensure that all experimental processes are fully documented, traceable and in compliance with global drug registration filing requirements.
- We offer a customized and flexible service model based on the specific needs of our clients.
We provide one-stop solutions to meet our clients' needs for research and quality standardization throughout the drug life cycle, including RLD reverse engineering, generic drug development, product registration and manufacturing, and quality standardization. We are committed to working closely with our clients to ensure that all their needs are met and that we provide timely and professional technical support. If you are interested in our services or have questions, please feel free to contact us.
